The Greifswald Post COVID Rehabilitation Study and Research (PoCoRe)-Study Design, Characteristics and Evaluation Tools.

(1) Background: COVID-19 is often associated with significant long-term symptoms and disability, i.e., the long/post-COVID syndrome (PCS). Even after presumably mild COVID-19 infections, an increasing number of patients seek medical help for these long-term sequelae, which can affect various organ systems. The pathogenesis of PCS is not yet understood. Therapy has so far been limited to symptomatic treatment. The Greifswald Post COVID Rehabilitation Study (PoCoRe) aims to follow and deeply phenotype outpatients with PCS in the long term, taking a holistic and comprehensive approach to the analysis of their symptoms, signs and biomarkers. (2) Methods: Post-COVID outpatients are screened for symptoms in different organ systems with a standardized medical history, clinical examination, various questionnaires as well as physical and cardiopulmonary function tests. In addition, biomaterials are collected for the analysis of immunomodulators, cytokines, chemokines, proteome patterns as well as specific (auto)antibodies. Patients are treated according to their individual needs, adhering to the current standard of care. PoCoRe's overall aim is to optimize diagnostics and therapy in PCS patients.

Biobanking: A foundation of life-science research and advancement

As a foundation of life-science research and advancement, biobanking has played a critical role and made tremendous contributions to healthcare, biotechnology, disease control and prevention, as well as bio-conservation for the benefit of all humankind. This paper starts with a brief introduction of basic concepts, history, classification, and significance of biobanking, followed by a discussion on cryobiology fundamentals and key challenges faced by cryopreservation in biobanking. A special case discussion on the cryopreservation and biobanking of pathogenic microorganisms to meet both the unmet needs for biomedical research and the urgent demand for developing countermeasures against the ongoing COVID-19 pandemic is highlighted with insightful recommendations for future studies.

Biobanking in LMIC settings for infectious diseases: Challenges and enablers.

Biobanking facilities are well established in high-income settings, where substantial funding has been invested in infrastructure. In contrast, such facilities are much less developed in resource-restricted settings. However, low-and middle-income countries (LMICs) still face a disproportionately high infectious diseases burden. Thus, the further development of infrastructure facilities, including biobanks is warranted as an important component of this unfolding clinical research environment. This perspective manuscript summarises the challenges and enablers for biobanking in LMICs, with a particular focus on infectious diseases, incorporating some of the lessons learned from the recent coronavirus disease 2019 (COVID-19) pandemic.

Biobanking in times of crisis - The COVID-19 Autopsy and Biosample Registry Baden-Wuerttemberg.

Biobanking plays a critical role in diagnostics, biomarker research and development of novel treatment approaches for various diseases. In urgent need of understanding, preventing and treating coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the importance of biobanking including data sharing and management further increased. To provide high quality tissue biomaterials and data for research and public health, the COVID-19 Autopsy and Biosample Registry was established in the state of Baden-Wuerttemberg (BW) in Germany, combining expertise and technologies of the Institutes of Pathology of the five university hospitals in BW (Heidelberg, Tübingen, Ulm, Freiburg, Mannheim). The COVID-19 Autopsy and Biosample Registry BW comprises tissue samples from autopsies and associated data of deceased patients in the context of SARS-CoV-2 infection and/or vaccination against SARS-CoV-2. The aim is to collect autopsy biospecimens, associated clinical and diagnostic data in a timely manner, register them, make them accessible for research projects and thus to support especially tissue-related research addressing COVID-19. By now, the BW network holds multiple collaborations and supported numerous publications to increase the understanding of COVID-19 disease. The achievements of the BW network as a landmark biobanking model project represent a potential blueprint for future disease-related biobanking and registry effort.

Views of university students in Jordan towards Biobanking.

BACKGROUND: Biobanks are considered primary means+ of supporting contemporary research, in order to deliver personalized and precise diagnostics with public acceptance and participation as a cornerstone for their success. AIMS: This study aims to assess knowledge, perception, and attitudes towards biomedical research and biobanking among students at the University of Jordan. METHODOLOGY: An online questionnaire was designed, developed, and piloted. It was divided into 5 sections that included questions related to issues of biomedical research and biobanking as well as factors influencing the decision to participate. RESULTS: Responses from 435 students revealed that 52.9% previously heard of biobanks. There was an overwhelming acceptance for participation in biomedical, genetic, and biobanking research. A blood sample was the most preferred for donation. Protection of privacy, informed consent prior to donation, approval of an ethics committee, and trust towards researchers were the most important factors associated with willingness to participate. On the other hand, the vagueness of the type of research performed on the biospecimens and the unavailability of general research results to the donor had a negative connotation. There was no clear agreement on the type of informed consent preferred by students, but to be contacted and informed of research results was preferred by the majority. Students also preferred the disposal of biospecimens and information when deciding to withdraw from participation. CONCLUSION: There is strong enthusiasm among students to participate in biomedical research and biobanking with all rights reserved thus providing hope for a very promising future in Jordan.

Biobanking: Strengthening Uganda's Rapid Response to COVID-19 and Other Epidemics.

Introduction: SARS-CoV-2 is a fatal disease of global public health concern. Measures to reduce its spread critically depend on timely and accurate diagnosis of virus-infected individuals. Biobanks can have a pivotal role in elucidating disease etiology, translation, and advancing public health. In this article, we show how a biobank has been a critical resource in the rapid response to coronavirus disease of 2019 (COVID-19) in Uganda. Materials and Methods: The Integrated Biorepository of H3Africa Uganda established a COVID-19 biobank. Standard Operating Procedures for sample and data collection, sample processing, and storage were developed. An e-questionnaire data tool was used to collect sociodemographic factors. Samples were collected at 7-day intervals from patients, analyzed for key parameters, processed, annotated, characterized, and stored at appropriate temperatures. Results: Stored samples have been used in validation of 17 diagnostic kits, the Cepheid Xpert Xpress SARS-CoV-2 assay, as well as a sample pooling technique for mass screening and polymerase chain reaction assay validation. Kits that passed validation were deployed for mass screening boosting early detection, isolation, and treatment of COVID-19 cases. Also, 10 applications from researchers and biotech companies have been received and approved and 4 grants have been awarded Conclusion: The CoV-Bank has proven to be an invaluable resource in the fight against the COVID-19 pandemic in Uganda, as samples have been resources in the validation and development of COVID-19 diagnostic tools, which are important in tracing and isolation of infected cases to confront, delay, and stop the spread of the SARS-CoV-2 virus.

The Use of Saliva as a Biosample in the Light of COVID-19.

Saliva is easy to collect and a biofluid that is readily available without the need for special equipment for its collection. The collection process, which is non-invasive and inexpensive, leads to obtaining a biomaterial that can serve as a source of information for molecular diagnostics of diseases in general medicine, genetics and dentistry. Unfortunately, many of the salivary methodologies are lacking important parameters to provide for not only the safety of the operator, but also the quality and reproducibility of the research. Since the COVID-19 pandemic, salivary diagnostics demonstrate a great potential for research of SARS-CoV 2. In this review, good practice for unstimulated saliva collection and patient preparation was provided, based on the latest literature and available guidelines. Schemes for saliva collection procedures were presented following an extended literature search. Descriptions of salivary probes/cups, techniques of saliva collection, and the use of specific buffering solutions for the stability of collected samples for SARS-CoV-2 detection were also evaluated.

Evaluation of formulations to improve SARS-CoV-2 viability and thermostability after lyophilisation.

In the context of the COVID-19 pandemic, virus collections such as EVA-GLOBAL play a key role in the supply of viruses and related products for research. Freeze-drying techniques for viruses represent a method of choice for the preservation of strains and their distribution without the need for a demanding cold chain. Here, we describe an optimised lyophilisation protocol usable for SARS-CoV-2 strains that improves preservation and thermostability. We show that sucrose used as an adjuvant represents a simple and efficient stabilizer providing increased protection for long-term preservation and shipment of the virus under different climatic conditions.

Making a complex dental care tailored to the person: population health in focus of predictive, preventive and personalised (3P) medical approach.

An evident underestimation of the targeted prevention of dental diseases is strongly supported by alarming epidemiologic statistics globally. For example, epidemiologists demonstrated 100% prevalence of dental caries in the Russian population followed by clinical manifestation of periodontal diseases. Inadequately provided oral health services in populations are caused by multi-factorial deficits including but not limited to low socio-economic status of affected individuals, lack of insurance in sub-populations, insufficient density of dedicated medical units. Another important aspect is the "participatory" medicine based on the active participation of population in maintaining oral health: healthcare will remain insufficient as long as the patient is not motivated and does not feel responsible for their oral health. To this end, nearly half of chronically diseased people do not comply with adequate medical services suffering from severely progressing pathologies. Noteworthy, the prominent risk factors and comorbidities linked to the severe disease course and poor outcomes in COVID-19-infected individuals, such as elderly, diabetes mellitus, hypertension and cardiovascular disease, are frequently associated with significantly altered oral microbiome profiles, systemic inflammatory processes and poor oral health. Suggested pathomechanisms consider potential preferences in the interaction between the viral particles and the host microbiota including oral cavity, the respiratory and gastrointestinal tracts. Since an aspiration of periodontopathic bacteria induces the expression of angiotensin-converting enzyme 2, the receptor for SARS-CoV-2, and production of inflammatory cytokines in the lower respiratory tract, poor oral hygiene and periodontal disease have been proposed as leading to COVID-19 aggravation. Consequently, the issue-dedicated expert recommendations are focused on the optimal oral hygiene as being crucial for improved individual outcomes and reduced morbidity under the COVID-19 pandemic condition. Current study demonstrated that age, gender, socio-economic status, quality of environment and life-style, oral hygiene quality, regularity of dental services requested, level of motivation and responsibility for own health status and corresponding behavioural patterns are the key parameters for the patient stratification considering person-tailored approach in a complex dental care in the population. Consequently, innovative screening programmes and adapted treatment schemes are crucial for the complex person-tailored dental care to improve individual outcomes and healthcare provided to the population.

High-resolution serum proteome trajectories in COVID-19 reveal patient-specific seroconversion.

A deeper understanding of COVID-19 on human molecular pathophysiology is urgently needed as a foundation for the discovery of new biomarkers and therapeutic targets. Here we applied mass spectrometry (MS)-based proteomics to measure serum proteomes of COVID-19 patients and symptomatic, but PCR-negative controls, in a time-resolved manner. In 262 controls and 458 longitudinal samples of 31 patients, hospitalized for COVID-19, a remarkable 26% of proteins changed significantly. Bioinformatics analyses revealed co-regulated groups and shared biological functions. Proteins of the innate immune system such as CRP, SAA1, CD14, LBP, and LGALS3BP decreased early in the time course. Regulators of coagulation (APOH, FN1, HRG, KNG1, PLG) and lipid homeostasis (APOA1, APOC1, APOC2, APOC3, PON1) increased over the course of the disease. A global correlation map provides a system-wide functional association between proteins, biological processes, and clinical chemistry parameters. Importantly, five SARS-CoV-2 immunoassays against antibodies revealed excellent correlations with an extensive range of immunoglobulin regions, which were quantified by MS-based proteomics. The high-resolution profile of all immunoglobulin regions showed individual-specific differences and commonalities of potential pathophysiological relevance.

Building Research Support Capacity across Human Health Biobanks during the COVID-19 Pandemic.

Human health biobanks are forms of research infrastructure that supply biospecimens and associated data to researchers, and therefore juxtapose the activities of clinical care and biomedical research. The discipline of biobanking has existed for over 20 years and is supported by several international professional societies and dedicated academic journals. However, despite both rising research demand for human biospecimens, and the growth of biobanking as an academic discipline, many individual biobanks continue to experience sustainability challenges. This commentary will summarize how the COVID-19 pandemic is creating new challenges and opportunities for both the health biobanking sector and the supporting discipline of biobanking. While the challenges for biobanks may be numerous and acute, there are opportunities for both individual biobanks and the discipline of biobanking to embrace change such that biobanks can continue to support and drive biomedical research. We will therefore describe numerous practical steps that individual biobanks and/or the discipline of biobanking can take to survive and possibly thrive in response to the COVID-19 pandemic.

Building biorepositories in the midst of a pandemic.

Biospecimen repositories play a vital role in enabling investigation of biologic mechanisms, identification of disease-related biomarkers, advances in diagnostic assays, recognition of microbial evolution, and characterization of new therapeutic targets for intervention. They rely on the complex integration of scientific need, regulatory oversight, quality control in collection, processing and tracking, and linkage to robust phenotype information. The COVID-19 pandemic amplified many of these considerations and illuminated new challenges, all while academic health centers were trying to adapt to unprecedented clinical demands and heightened research constraints not witnessed in over 100 years. The outbreak demanded rapid understanding of SARS-CoV-2 to develop diagnostics and therapeutics, prompting the immediate need for access to high quality, well-characterized COVID-19-associated biospecimens. We surveyed 60 Clinical and Translational Science Award (CTSA) hubs to better understand the strategies and barriers encountered in biobanking before and in response to the COVID-19 pandemic. Feedback revealed a major shift in biorepository model, specimen-acquisition and consent process from a combination of investigator-initiated and institutional protocols to an enterprise-serving strategy. CTSA hubs were well equipped to leverage established capacities and expertise to quickly respond to the scientific needs of this crisis through support of institutional approaches in biorepository management.

Severe Acute Respiratory Syndrome Coronavirus 2 and Coronavirus Disease 2019: A Clinical Overview and Primer.

Following its emergence in December 2019, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused what rapidly became a global pandemic. The precise origin and subsequent path of transmission have not yet been established-but like the other novel coronaviruses that it closely resembles, it appears to have evolved naturally in a bat host. The disease caused by SARS-CoV-2 infection, designated as coronavirus disease 2019 (COVID-19), ranges from asymptomatic, to mild self-limited illness, to progressive pneumonia, respiratory compromise, multiorgan failure, and death. In addition, a hyperinflammatory disease state occurs in a subset of patients, and may be seen either during acute infection or following recovery. The search for effective pharmacological management of COVID-19 continues, but several promising candidates have been identified, including the viral nucleoside analog remdesivir. However, despite the existence of literally thousands of clinical trials, the management of COVID-19 remains challenging, and the development of an optimal, evidence-based therapeutic approach is ongoing. The impact of SARS-CoV-2 and COVID-19 on the biobanking world is evolving and profound-in particular, it is likely that many of mysteries surrounding COVID-19 will be solved via the availability of high-quality, large-scale collection, storage, and analysis of patient specimens. The purpose of this review article is therefore to provide a rapid, comprehensive, and relevant overview and primer on SARS-CoV-2 and COVID-19, with attention to the epidemiology, virology, transmission, clinical features, and major therapeutic options currently existent.

A Study of Policies and Guidelines for Collecting, Processing, and Storing Coronavirus Disease 2019 Patient Biospecimens for Biobanking and Research.

Biobanking has been playing a crucial role in the development of new vaccines, drugs, biotechnology, and therapeutics for the prevention and treatment of a wide range of human diseases. This puts biobanks at the forefront of responding to the ongoing worldwide outbreak of the severe pandemic, coronavirus disease 2019 (COVID-19). The leading public health institutions around the world have developed and established interim policies and guidelines for researchers and biobank staff to handle the infectious biospecimens safely and adequately from COVID-19 patients. A study of these important and complementary policies and guidelines is conducted in this study. It should be emphasized that the COVID-19 biospecimens must be collected, processed, and preserved by trained personnel equipped with right personal protective equipment to prevent the transmission of the coronavirus and ensure the specimen quality for testing and research. Six of the leading global public health organizations or institutions included in this study are the World Health Organization, the Pan American Health Organization, the U.S. Centers for Disease Control and Prevention, the Public Health England, the U.S. Food and Drug Administration, and the Office of Research at the University of California, San Francisco. In conclusion, following the recommended guidance and policies with extreme precautions is essential to ensure the quality of the collected COVID-19 biospecimens and accuracy of the conducted research or treatment, and prevent any possible transmission. Efforts from cryobiologist and biobanking engineers to optimize the protocol of COVID-19 biospecimen cryopreservation and develop the user-friendly and cost-effective devices are urgently required to meet the urgent and increased needs in the specimen biobanking and transportation.

Biospecimen Collection During the COVID-19 Pandemic.

OBJECTIVES: Millions of biospecimens will be collected during the coronavirus disease 2019 (COVID-19) pandemic. As learned from severe acute respiratory syndrome (SARS), proper biospecimen handling is necessary to prevent laboratory-related infections. METHODS: Centers for Disease Control and Prevention and World Health Organization severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) interim biosafety guidelines continue to be updated. Presented here are additional considerations intended to complement the interim guidance. These considerations draw on prior SARS recommendations and recent COVID-19 reports. RESULTS: SARS-CoV-2 viral RNA has been detected in various biospecimen types; however, studies are needed to determine whether viral load indicates viable virus. Throughout the pandemic, biospecimens will be collected for various purposes from COVID-19 known and suspected cases, as well as presymptomatic and asymptomatic individuals. Current data suggest the pandemic start may be as early as October 2019; thus, all biospecimens collected since could be considered potentially infectious. CONCLUSIONS: All entities handling these biospecimens should do risk assessments in accordance with institutional policies and adhere to any guidance provided. The scientific community has a responsibility to safely handle and maintain all biospecimens collected during the COVID-19 pandemic. Soon, it will be imperative to convene expert working groups to address the current and long-term storage and use of these biospecimens. Ideally, worldwide guidelines will be established to protect the personnel handling these biospecimens and communities at large.

Biobanking in the COVID-19 Era and Beyond: Part 2. A Set of Tool Implementation Case Studies.

The COVID-19 era has brought about a number of novel challenges for the global biobanking community. An array of diverse tools (e.g., standards, best practices, and plans) exists to support quality and fitness-for-purpose in biobank operations. The International Society for Biological and Environmental Repositories (ISBER) COVID-19 Response Task Force has set out to identify needs and gaps in these tools and make recommendations for the next generation of available tools, having closely examined the COVID-19-related challenges. While conducting this work to examine the relationships between tools and biobank adaptability, a subgroup of the task force conducted a parallel effort to develop and describe individual COVID-19 era case studies based on a number of operating biobanks. Each case study presents a different combination of implemented tools. Observations and lessons learned from these case studies are provided, and experiences with tool implementation are discussed. This information is supplemented by data relating to tool usefulness that was obtained through an ISBER survey discussed in a companion article. The knowledge gained from this study will be combined with other task force efforts to make recommendations to better position the biobanking community in their response to future emergencies.

The Importance of Biobanking for Response to Pandemics Caused by Emerging Viruses: The European Virus Archive As an Observatory of the Global Response to the Zika Virus and COVID-19 Crisis.

When a new virus emerges and causes a significant epidemic, the emergency response relies on diagnostics, surveillance, testing, and proposal of treatments if they exist, and also in the longer term, redirection of research efforts toward understanding the newly discovered pathogen. To serve these goals, viral biobanks play a crucial role. The European Virus Archive (EVA) is a network of biobanks from research laboratories worldwide that has combined into a common set of practices and mutually beneficial objectives to give scientists the tools that they need to study viruses in general, and also to respond to a pandemic caused by emerging viruses. Taking the most recent outbreaks of the Zika virus and SARS-CoV-2 as examples, by looking at who orders what and when to the EVA, we illustrate how the global science community at large, public health, fundamental research and private companies, reorganize their activity toward diagnosing, understanding, and fighting the new pathogen.

Modeling consent in the time of COVID-19.

Effective responses to the COVID-19 pandemic require novel solutions for research and responsible data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19. In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19. The approach aims to link three levels of participation: COVID-19 patients, respiratory/infectious disease patients, and longitudinal study participants. We explore the potential approaches that can be taken to consent processes with these three participant groups. We furthermore describe an access model for both single-site and multi-site data and sample storage. Through dealing with these topics at a high level, the model may be adapted to local legal and ethical requirements while still pursuing its ultimate goal: the creation of a research infrastructure that supports transparent, strong, and open science.

The urgency of utilizing COVID-19 biospecimens for research in the heart of the global pandemic.

The outbreak of the novel coronavirus disease 2019 (COVID-19) and consequent social distancing practices have disrupted essential clinical research functions worldwide. Ironically, this coincides with an immediate need for research to comprehend the biology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the pathology of COVID-19. As the global crisis has already led to over 15,000 deaths out of 175,000 confirmed cases in New York City and Nassau County, NY alone, it is increasingly urgent to collect patient biospecimens linked to active clinical follow up. However, building a COVID-19 biorepository amidst the active pandemic is a complex and delicate task. To help facilitate rapid, robust, and regulated research on this novel virus, we report on the successful model implemented by New York University Langone Health (NYULH) within days of outbreak in the most challenging hot spot of infection globally. Using an amended institutional biobanking protocol, these efforts led to accrual of 11,120 patients presenting for SARS-CoV-2 testing, 4267 (38.4%) of whom tested positive for COVID-19. The recently reported genomic characterization of SARS-CoV-2 in the New York City Region, which is a crucial development in tracing sources of infection and asymptomatic spread of the novel virus, is the first outcome of this effort. While this growing resource actively supports studies of the New York outbreak in real time, a worldwide effort is necessary to build a collective arsenal of research tools to deal with the global crisis now, and to exploit the virus's biology for translational innovation that outlasts humanity's current dilemma.